Efficacy and Safety of QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma: a Phase II Clinical Study
This is a single-center, open-label phase II study of QL1706 for the treatment of advanced bone and soft tissue sarcomas.The study includes screening period, treatment period and follow-up period. Subjects will receive QL1706 5mg/kg iv every 3 weeks until disease progression or intolerance. Efficacy should be evaluated and safety will be monitored throughout the study.
• Male or female subjects aged between 18 and 75 years .
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• An unresectable locally advanced or metastatic sarcoma of bone and soft tissue confirmed by local histopathology, including acinar soft tissue sarcoma, pleomorphic undifferentiated sarcoma, chordoma, hemangiosarcoma and synovial sarcoma.
• For subtypes without standard systemic treatment options, such as acinar soft tissue sarcoma, chordoma, no systemic treatment needed.
• For subtypes with standard systemic treatment options, such as synovial sarcoma, pleomorphic undifferentiated sarcoma, and angiosarcoma, anthracycline-based chemotherapy is required.
• Subjects can provide tumor tissue samples and blood samples for biomarker testing such as PD-L1.
• Life expectancy of ≥3 months.
• The functional level of important organs must meet the requirements before the first dose of study drug.
• Male and female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.Female subjects who are not pregnant or breastfeeding.
⁃ Subjects participate voluntarily with sign a signed informed consent form (ICF) and are able to follow the study protocol.